JP2009510068A5 - - Google Patents
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- JP2009510068A5 JP2009510068A5 JP2008533471A JP2008533471A JP2009510068A5 JP 2009510068 A5 JP2009510068 A5 JP 2009510068A5 JP 2008533471 A JP2008533471 A JP 2008533471A JP 2008533471 A JP2008533471 A JP 2008533471A JP 2009510068 A5 JP2009510068 A5 JP 2009510068A5
- Authority
- JP
- Japan
- Prior art keywords
- direct compression
- tablet
- active ingredient
- granulation
- melt
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 238000007907 direct compression Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- XEKOWRVHYACXOJ-UHFFFAOYSA-N acetic acid ethyl ester Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drugs Drugs 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000007909 melt granulation Methods 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- DNIAPMSPPWPWGF-UHFFFAOYSA-N propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 2
- 238000005550 wet granulation Methods 0.000 description 2
- CTPDSKVQLSDPLC-UHFFFAOYSA-N 2-(oxolan-2-ylmethoxy)ethanol Chemical compound OCCOCC1CCCO1 CTPDSKVQLSDPLC-UHFFFAOYSA-N 0.000 description 1
- 229960003105 Metformin Drugs 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000007891 compressed tablet Substances 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000009474 hot melt extrusion Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- KFZMGEQAYNKOFK-UHFFFAOYSA-N iso-propanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 1
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Description
製薬業者は迅速な加工時間および経費の利点のために、湿式または乾式造粒法よりも直接圧縮技術の使用を好む。しかしながら通常直接圧縮は、薬物または活性成分が薬学的に許容される錠剤を形成するために要求される物理的特性を有するこれらの状況に限定される。しかしながら直接圧縮法を使用できる前に、多くの成分が必要な特性を有していないので、しばしば一つまたはそれより多い賦形剤を活性成分と組み合わせなければならない。製剤に添加される各賦形剤は最終製品の錠剤の大きさを増すので、製造者は、直接圧縮法の使用をしばしば圧縮錠剤あたり低用量の活性成分を含有する製剤に限定される。 Pharmaceutical companies prefer the use of direct compression techniques over wet or dry granulation because of the advantages of rapid processing time and cost. However, direct compression usually is limited to those situations where the drug or active ingredient has the physical properties required to form a pharmaceutically acceptable tablet. However, before many direct compression methods can be used, often one or more excipients must be combined with the active ingredient since many ingredients do not have the necessary properties. Since each excipient added to the formulation increases the tablet size of the final product, the manufacturer is restricted to the use of direct compression often manufactured agent containing the active ingredient per compressed tablet low doses.
メトホルミン顆粒が湿式造粒により水またはエタノール、イソプロパノール、酢酸エチル、グリコフロール、プロピレングリコールのような有機溶媒から選択される溶媒を用いて生成される本明細書で記載されるような錠剤または医薬組成物。
メトホルミン顆粒が溶融造粒により生成される本明細書で記載されるような錠剤または医薬組成物。溶融造粒過程は「Hot-melt extrusion Technique」: A Review;Iranian Journal of Pharmaceutical Research 3:3-16(2004);Rina Chokshi et al. または総説Joerg Breitenbach 「Melt extrusion: from process to drug delivery technology」: European Journal of Pharmaceutics and Biopharmaceutics 54:107-117(2002)(双方を出典明示により本明細書の一部とする)のような多くの出版物に記載されている。
Water or ethanol Metohorumi emissions granule is by wet granulation, isopropanol, ethyl acetate, glycofurol, tablets such as described herein that is produced by using a solvent selected from organic solvents such as propylene glycol or Pharmaceutical composition.
A tablet or pharmaceutical composition as described herein wherein metformin granules are produced by melt granulation. Melt granulation process is "Hot-melt extrusion Technique": A Review; Iranian Journal of Pharmaceutical Research 3: 3-16 (2004); Rina Chokshi et al. Or review Joerg Breitenbach "Melt extrusion: from process to drug delivery technology" : Published in many publications such as the European Journal of Pharmaceutics and Biopharmaceutics 54: 107-117 (2002), both of which are hereby incorporated by reference.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US72262405P | 2005-09-29 | 2005-09-29 | |
US60/722,624 | 2005-09-29 | ||
PCT/US2006/037198 WO2007041053A2 (en) | 2005-09-29 | 2006-09-25 | Formulation comprising metformin and vildagli ptin |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013146163A Division JP2013241429A (en) | 2005-09-29 | 2013-07-12 | New formulation |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2009510068A JP2009510068A (en) | 2009-03-12 |
JP2009510068A5 true JP2009510068A5 (en) | 2009-11-05 |
JP5415762B2 JP5415762B2 (en) | 2014-02-12 |
Family
ID=37876819
Family Applications (8)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008533471A Active JP5415762B2 (en) | 2005-09-29 | 2006-09-25 | New formulation |
JP2013146163A Withdrawn JP2013241429A (en) | 2005-09-29 | 2013-07-12 | New formulation |
JP2015201008A Active JP6270793B2 (en) | 2005-09-29 | 2015-10-09 | New formulation |
JP2017202104A Withdrawn JP2018052945A (en) | 2005-09-29 | 2017-10-18 | Novel formulations |
JP2019042906A Withdrawn JP2019131567A (en) | 2005-09-29 | 2019-03-08 | Novel formulation |
JP2020151616A Active JP7194153B2 (en) | 2005-09-29 | 2020-09-09 | New formulation |
JP2022065829A Pending JP2022106763A (en) | 2005-09-29 | 2022-04-12 | Novel formulations |
JP2023193231A Pending JP2024028702A (en) | 2005-09-29 | 2023-11-13 | New formulation |
Family Applications After (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013146163A Withdrawn JP2013241429A (en) | 2005-09-29 | 2013-07-12 | New formulation |
JP2015201008A Active JP6270793B2 (en) | 2005-09-29 | 2015-10-09 | New formulation |
JP2017202104A Withdrawn JP2018052945A (en) | 2005-09-29 | 2017-10-18 | Novel formulations |
JP2019042906A Withdrawn JP2019131567A (en) | 2005-09-29 | 2019-03-08 | Novel formulation |
JP2020151616A Active JP7194153B2 (en) | 2005-09-29 | 2020-09-09 | New formulation |
JP2022065829A Pending JP2022106763A (en) | 2005-09-29 | 2022-04-12 | Novel formulations |
JP2023193231A Pending JP2024028702A (en) | 2005-09-29 | 2023-11-13 | New formulation |
Country Status (33)
Country | Link |
---|---|
US (4) | US20080227825A1 (en) |
EP (1) | EP1948149B2 (en) |
JP (8) | JP5415762B2 (en) |
KR (2) | KR101595169B1 (en) |
CN (1) | CN101277688B (en) |
AR (1) | AR055441A1 (en) |
AT (1) | ATE533481T1 (en) |
AU (1) | AU2006297444B2 (en) |
BR (1) | BRPI0616694B8 (en) |
CA (1) | CA2623011C (en) |
CY (1) | CY1112305T1 (en) |
DK (1) | DK1948149T4 (en) |
EC (1) | ECSP088318A (en) |
ES (1) | ES2377572T5 (en) |
GT (1) | GT200600426A (en) |
HK (1) | HK1121372A1 (en) |
IL (1) | IL189856A (en) |
JO (2) | JOP20180109A1 (en) |
MA (1) | MA29854B1 (en) |
MY (1) | MY144975A (en) |
NO (2) | NO346101B1 (en) |
NZ (1) | NZ566430A (en) |
PE (1) | PE20070583A1 (en) |
PH (1) | PH12014500051A1 (en) |
PL (1) | PL1948149T5 (en) |
PT (1) | PT1948149E (en) |
RU (1) | RU2483716C9 (en) |
SG (4) | SG10201401826TA (en) |
SI (1) | SI1948149T2 (en) |
TN (1) | TNSN08146A1 (en) |
TW (1) | TWI389685B (en) |
WO (1) | WO2007041053A2 (en) |
ZA (1) | ZA200801773B (en) |
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GT200600008A (en) * | 2005-01-18 | 2006-08-09 | FORMULATION OF DIRECT COMPRESSION AND PROCESS | |
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JOP20180109A1 (en) * | 2005-09-29 | 2019-01-30 | Novartis Ag | New Formulation |
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